1. Field of the Invention
The present invention relates to a composition and method for reducing the risk or progression of cardiovascular, glaucoma and tardive dyskinesia diseases and, more particularly, to a composition containing a number of ingredients which are present in amounts lower than amounts considered harmful to the body but which act synergistically to provide enhanced disease inhibition.
2. Description of Related Art
Cardiovascular disease is the most frequent cause of death in industrialized countries. Atherosclerosis (AS) is the principal cause of cardiovascular disease. AS is a disease of the intima of the arteries that leads to fatty lesions called artheromatous plaques on the inside surface of the arteries. This deposit of fat and cholesterol narrows the arteries, and often becomes calcified, providing sites for abnormal blood clots to form, leading to high blood pressure, heart attacks and strokes.
Elevated plasma homocysteine (Hcy) concentrations have repeatedly been associated with increased vascular risk. Hcy causes cells to decrease their production of clot preventing and clot dissolving substances and increases production of clot promoting substances. Hcy is an intermediate sulfhydryl alpha-amino acid formed during conversion of methionine to cysteine.
The buildup of Hcy in the body leads to overproduction of homocysteine thiolactone that causes low density lipoprotein (LDL) to become aggregated, and start to form plaque on the artery walls. Highly reactive oxygen radicals accumulate within this plaque resulting in damage to the lining cells of arteries, promoting blood clot formation and stimulating growth of arterial muscle cells which form fiberous tissue, mucoid matrix and degenerative elastic tissue (McCully K. The Homocysteine Revolution, Keats Publishers, Lincolnwood Ill.).
Thus, the presence of Hcy in the body has come to be a predictor of heart attacks, strokes, deep vein thrombosis and other circulatory problems. Evidence from The Life Extension Foundation indicates there is no xe2x80x9csafexe2x80x9d normal range for Hcy. However, epidemiological data reveals that Hcy levels above 6.3 cause a steep progressive risk of heart attack. A method of lowering Hcy would prevent and/or inhibit these serious problems.
Dextromethorphan (DM) has recently been shown to decrease the levels of Hcy as discussed in U.S. Pat. No. 6,025,369. The amount of DM necessary to reduce Hcy to safe levels can cause undesirable side effects however.
Hcy and its degradation products are putative neurotransmitters and agonists at the N-methyl-D-aspartate (NMDA) receptor (Neuroreport 2000, August. 21; 11(12):2749-52). It has been shown that Hcy acts as an agonist at the glutamine binding side of the NMDA receptor (one type of excitatory amino acid receptor). Dextromethorphan (DM), a widely used OTC antitussive agent, is a noncompetitive antagonist of the NMDA receptor and is protective against the adverse effect of Hcy and its metabolites. DM, the d-isomer of the opiate agonist levorphanol, has none of the analgesic or sedative effects associated with the opiates. DM, acting as an antagonist at NMDA receptors, suppress the transmission of nerve impulses and nerve signals mediated through NMDA receptors. In addition, DM has also been reported to suppress activity at neuronal calcium channels.
Dextromethorphan and other NMDA receptor antagonists are known for treating glaucoma as discussed in U.S. Pat. No. 5,922,773 issued on Jul. 13, 1999 to Lipton et al. and for treating tardive dyskinesia as shown in U.S. Pat. No. 5,866,585 issued on Feb. 2, 1999 to Fogel. Both patents are hereby incorporated by reference.
Vitamin supplements of folic acid, B6 and B12 have been shown to be useful in lowering Hcy but there is evidence that for some elderly people it is not sufficient to keep the level of Hcy low enough to be out of the danger zone.
Bearing in mind the problems and deficiencies of the prior art, it is therefore an object of the present invention to provide a composition for reducing the risk or progression of cardiovascular diseases.
It is another object of the present invention to provide a composition for reducing the risk or progression of glaucoma.
A further object of the invention is to provide a composition for reducing the risk or progression of tardive dyskinesia disease.
It is yet another object of the present invention to provide a method for reducing the risk or progression of cardiovascular diseases in a person by administering to the person a composition of the invention.
Another object of the invention is to provide a method for reducing the risk or progression of glaucoma by administering to a person a composition according to the invention.
An additional object of the invention is to provide a method for reducing the risk or progression of tardive dyskinesia diseases by administering to a person a composition of the invention.
Still other objects and advantages of the invention will in part be obvious and will in part be apparent from the specification.
The above and other objects, which will be apparent to those skilled in art, are achieved in the present invention which is directed to a composition comprising a mixture of ingredients and a method for using the composition to reduce the risk or progression of cardiovascular, glaucoma and tardive dyskinesia diseases. The composition comprises a mixture of ingredients which act synergistically to provide the desired therapeutic effect. Broadly stated, levels of homocysteine are decreased in the plasma using known ingredients which are present in amounts below the amount which would cause harmful effects in the body yet still provide the desired therapeutic effects. Dextromethorphan (DM) in combination with folic acid, vitamin B6 and vitamin B12 are essential ingredients of the composition. Preferred compositions contain one or more of lecithin, vitamin E, beta-carotene, phytochemicals (e.g., proanthocyanidins, cyanidin, procyanidin, flavonoids, bioflavonoids), ginkgo biloba, trimethylglycine, garlic oil, vinpocetine, omega-3-oils, pantothenic acid, vitamin B3, herbs such as kava and minerals, especially selenium, zinc, magnesium and calcium.
It is also preferred to employ in the composition a free radical inhibitor/antioxidant such as butylated hydroxytoluene (BHT) to protect the amino group in DM from oxidation and to provide a longer plasma level of DM.
In another aspect of the invention the composition may be used for preventing and/or treating glaucoma and damage to retinal ganglion cells using the composition of the invention further preferably including bilberry, bioflavonoids and beta-carotene and also oligomeric proanthocyanidins (OPC), vinpocetine and omega-3-oils.
In still another aspect of the invention the composition may be used for preventing and/or treating tardive dyskinesia using the composition of the invention further including antioxidants such as grape seed extract and pine bark extract, lecithin and oligomeric proanthocyanidins and also pantothenic acid, vitamin B3, omega-3-oils and herbs such as kava.
In another aspect of the invention a method is provided for reducing the risk of or progression of cardiovascular, glaucoma and tardive dyskinesia diseases wherein the composition of the invention is administered by oral, sublingual, buccal, transdermal and intramuscular and intravenous means. Oral compositions may be formed into a soft-gel article, capsule, tablets, tablet with coating, sustained release or granular product.